Search Results

Jedmed ORL Video Nasopharyngo-Laryngoscopes are intended to examine the larynx, nasal cavity and nasal pharynx. They are used between the upper respiratory tracts of the nasal passage and vocal cords.

This flexible scope is designed with the insertion tube with its bendable distal tip w/camera, the handle, the umbilical unit which has the leakage tester, and connection for light source port and power/video port The handle incorporates the control lever to bend the distal tip.

The provided text describes a 510(k) premarket notification for the "ORL Video Nasopharyngo-Laryngoscope." It references a study conducted to demonstrate substantial equivalence to predicate devices, but it does not describe an AI medical device or a study involving AI. Therefore, I will respond to the prompt by extracting the relevant information about the non-AI device's acceptance criteria and study, indicating where certain AI-specific questions are not applicable.

Here's the information extracted from the provided text, formatted to address your questions:

Acceptance Criteria and Device Performance Study for the ORL Video Nasopharyngo-Laryngoscope

This document describes a 510(k) premarket notification for a medical device that does not involve Artificial Intelligence (AI). The study conducted was to demonstrate substantial equivalence to predicate devices based on functional performance and cleaning/disinfection validation.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly list "acceptance criteria" for the functional tests with specific numerical targets. Instead, it states that the device was "found to be comparable" to the predicate device in several functional areas. The table below compares the specifications of the device under review with its predicate devices. The "acceptance criteria" here implicitly means that the performance values should be similar to or within acceptable ranges of the predicate devices for achieving substantial equivalence.

Predicate Device (K102733) Differences Noted:

• Working Length: 300mm (Device under review: 310mm)
• Depth of View: 3mm-50mm (Device under review: 10mm-55mm)
• Tube Diameter: 3mm (Device under review: 4mm)
• Angulation: 140° Up / 140° Down (Device under review: 130° Up / 130° Down)
• Product Code: EOB and HRX and GCJ (Device under review: EQN)
• Resolution: (Not explicitly stated for K102733, but K132039 provides a direct comparison)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a "sample size" in terms of number of patients or cases for the functional comparison. Instead, the "test set" consisted of the ORL Video Nasopharyngo-Laryngoscope itself and the predicate device (ErgoFlex Naso-Pharyngo-Laryngoscope K132039) which were tested in a controlled environment.

• Sample Size for Functional Test: Two devices (the new device and one predicate).
• Sample Size for Cleaning/Disinfection Test: The ORL Video Naso-Pharyngo-Laryngoscope.
• Data Provenance: The testing appears to have been conducted by the manufacturer (JEDMED Instrument Company) or a contracted laboratory (Geneva Laboratories for disinfection). The location is implied to be in the USA (St. Louis, Missouri). This was a prospective test conducted for the purpose of this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

For the functional testing, the comparison was performed by "knowledgeable field staff." The document does not specify the exact number of staff or their detailed qualifications (e.g., years of experience, specific certifications). For the cleaning and high-level disinfection test, it was performed by "Geneva Laboratories per the IFU," implying qualified laboratory personnel.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable as the study described is a technical comparison of device specifications and functional performance, not a clinical trial requiring ground truth adjudication by multiple experts for diagnostic outputs.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This question is not applicable as the device is not an AI medical device, and no MRMC study was conducted. The study was a comparison of device specifications and a validation of cleaning/disinfection.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable as the device is not an AI medical device. The functional comparison focuses on the device's inherent physical and optical characteristics.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the functional tests (Field of View, Depth of View, Angulation, Color Output, Clarity, Tip Diameter), the "ground truth" was established by direct measurement and observation of the device's technical specifications and performance against the known specifications of the predicate device.

For the cleaning and high-level disinfection test, the ground truth was microbiological reduction efficacy, validated against established standards for sterilization/disinfection (implied by "significant level of microbial reduction must result from tests for both vegetative microorganisms and mycobacteria").

8. The sample size for the training set

This question is not applicable as the device is not an AI medical device and does not involve a training set.

9. How the ground truth for the training set was established

This question is not applicable as the device is not an AI medical device and does not involve a training set.

Ask a specific question about this device

JEDMED's Ergo-Flex EF-N and EF-N Slim Laryngo-Nasopharyngoscopes are intended to examine the larynx, nasal cavity and nasal pharynx. They are used between the upper respiratory tracts of the nasal passage and the vocal cords.

This flexible scope is designed with the insertion tube with its bendable distal tip, the handle, the eyepiece and the focus ring. The handle incorporates the control lever to bend the distal tip and the connectors for the leakage tester and the fiber optic light-guide cable.

The provided document is a 510(k) premarket notification summary for the JEDMED Laryngo-Nasopharyngoscope EF-N and EF-N Slim. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness or clinical superiority. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed in terms of demonstrating equivalence through engineering and performance bench testing, rather than a clinical study with human subjects, ground truth, or expert consensus in the way those terms are typically used for AI/diagnostic devices.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission of this nature, the "acceptance criteria" are typically defined by engineering specifications, safety standards, and performance characteristics compared to the predicate device. The "reported device performance" are the results of bench testing to demonstrate compliance with these criteria and equivalence.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Testing: Not explicitly stated as a number of distinct devices for all tests. For example, "all tested scopes" for angulation implies multiple devices, but the exact number isn't quantified. For temperature testing, it refers to "4 different test sites" on the device.
• Data Provenance: The studies are bench tests and laboratory validations performed by the manufacturer, JEDMED Instrument Company, and Geneva Test Laboratory (for disinfection). This is not human data or clinical data; it's engineering and material testing. The country of origin of the data is implicitly the USA where JEDMED is located.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable in the typical sense for this device.

• There is no "ground truth" derived from human interpretation or clinical outcomes in the context of this 510(k) submission.
• The "acceptance criteria" are based on recognized standards (ISO, AAMI, IEC) and comparison to the predicate device's specifications. Compliance is measured via objective physical and chemical tests rather than expert consensus on a diagnostic outcome.
• The validation of reprocessing and biocompatibility would involve laboratory professionals and engineers.

4. Adjudication Method for the Test Set

Not applicable. There is no ambiguous "test set" requiring adjudication by multiple readers or experts. Performance is measured against objective standards and specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This is a premarket notification for a medical device (an endoscope), not a diagnostic AI algorithm. The submission focuses on demonstrating substantial equivalence in design, materials, and safety/performance characteristics to a legally marketed predicate device.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

Not applicable. This device is an endoscope, a tool used by a human clinician to visualize anatomical structures. It does not operate as an "algorithm only" or a "standalone" diagnostic system.

7. The Type of Ground Truth Used

Not applicable in the sense of expert consensus, pathology, or outcomes data for making diagnoses. The "ground truth" for this submission are:

• Established national and international standards for medical devices (e.g., ISO, AAMI, IEC).
• The engineering and performance specifications of the predicate device (Richard Wolf Medical Instruments Corp. flexible nasopharyngo-laryngoscope and flexible bronchoscope; K992526).
• Laboratory testing results (e.g., temperature measurements, cycle counts, chemical compatibility results).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As noted above, this is not an AI/machine learning device.

Ask a specific question about this device